BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II

    MDR report key: 17292322 · Received July 10, 2023

    Report

    Report Number
    9610825-2023-00341
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 20, 2023
    Report Date
    October 19, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). ROOT CAUSE ANALYSIS: SAMPLES EVALUATION: RECEIVED A SAMPLE WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BBC OF COMPLAINT SAMPLE WAS 23A22GED81. THE COMPLAINT SAMPLE WAS FILLED WITH SOLUTION AND BBC WAS OPENED. SUMMARY OF ROOT CAUSE ANALYSIS: THE COMPLAINT SAMPLE WAS DETECTED LEAKAGE AT TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION. THUS, WE CONSIDERED THIS COMPLAINT AS CONFIRMED. CAPA HAD BEEN RAISED TO ADDRESS TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION LEAKAGE ISSUE. CAUSE: FAILURE IN PRODUCTION PROCESS TO AVOID RECURRENCE OF THIS FAULT, CORRECTIVE MEASURE ALREADY HAS BEEN INITIATED. JUSTIFICATION: CONFIRMED NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN PORTUGAL: "CHEMO LEAKAGE." ACCORDING TO THE CUSOMER: "AFTER PREPARING THE INFUSER THAT WAS SENT TO THE DAY HOSPITAL, WHEN REMOVING IT FROM THE TRANSPORT BOX, THE NURSE SAW THAT THERE WAS A LEAK AT THE ENTRANCE DOOR OF INFUSER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251478 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG 22N10GED81

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown